Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
2026년 4월 30일 업데이트: Jun Ma, MD, Sun Yat-sen University
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
연구 개요
연구 유형
중재적
등록 (추정된)
130
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jun Ma
- 전화번호: +86-20-87343469
- 이메일: yangkb@sysucc.org.cn
연구 연락처 백업
- 이름: Yu-Pei Chen, MD
- 전화번호: +86-020-87343581
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국
- Sun Yat-sen University Cancer Center
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연락하다:
- Jun Ma
- 전화번호: +862087343469
- 이메일: majun2@mail.sysu.edu.cn
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수석 연구원:
- Jun Ma
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 18-70 years.
- Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).
- Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.
- Scheduled to receive radical intensity-modulated radiotherapy (IMRT).
- No prior history of anti-cancer treatment.
- ECOG performance status 0-1; adequate organ function within 2 weeks before enrollment; Hematology: hemoglobin > 90 g/L; absolute neutrophil count > 1.5×10⁹/L; platelet count > 100×10⁹/L. Biochemistry: total bilirubin ≤ 1.5×ULN; ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; creatinine clearance ≥ 50 mL/min.
- For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.
- Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.
Exclusion Criteria:
- Known intolerance or hypersensitivity to taurine or its excipients.
- Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Prior history of malignant tumor.
- Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)
- History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.
- Unwilling to stop smoking, drinking alcohol, or chewing betel nut.
- Presence of severe active comorbidities.
- Severe dysfunction of heart, brain, lung, or other vital organs.
- Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.
- Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.
- Any other condition deemed inappropriate by the investigator.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Taurine
Oral taurine 1 g twice daily, starting 3 days before radiotherapy until 1 week after completion of radiotherapy, plus standard of care for RIOM.
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Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
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간섭 없음: Control
Patients in the control arm will receive the standard of care for RIOM.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Severe Radiation-Induced Oral Mucositis
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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The incidence of Grade ≥3 radiation-induced oral mucositis (RIOM) in the experimental and control groups, as assessed using the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Onset Time of Severe Radiation-Induced Oral Mucositis
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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The interval from the start of radiotherapy to the first occurrence of severe radiation-induced oral mucositis (RIOM).
Severe RIOM is defined as Grade ≥3 according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Duration of Severe Radiation-Induced Oral Mucositis
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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The interval from the first occurrence of severe acute radiation-induced oral mucositis (RIOM) to its resolution to Grade ≤2, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Recovery Rate of Severe Radiation-Induced Oral Mucositis
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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The proportion of patients whose severe acute radiation-induced oral mucositis (RIOM) resolves to Grade ≤2 during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Incidence of Radiation-Induced Oral Mucositis
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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The proportion of patients who develop any-grade acute radiation-induced oral mucositis (RIOM) (Grade ≥1) during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Incidence of Radiotherapy Interruption
기간: From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
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The proportion of patients who experience a radiotherapy interruption of 5 or more consecutive days during the radiotherapy period due to acute radiation-induced oral mucositis (RIOM) or other related adverse events.
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From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
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Quality of life (QoL)
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Quality of life related to head and neck symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Module (EORTC QLQ-H&N35), version 1.0.
This questionnaire comprises 35 items, including seven multi-item scales and 11 single-item measures.
All scales and items will be scored according to the official EORTC Scoring Manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater symptom burden and poorer quality of life.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Numeric Rating Scale for Pain
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Oral mucositis-related pain was assessed in all participants using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate worse pain.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Safety as Assessed by CTCAE
기간: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Adverse events were monitored and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jun Ma, Sun Yat-sen University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 6일
기본 완료 (추정된)
2027년 3월 30일
연구 완료 (추정된)
2029년 3월 30일
연구 등록 날짜
최초 제출
2026년 4월 16일
QC 기준을 충족하는 최초 제출
2026년 4월 30일
처음 게시됨 (실제)
2026년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 30일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-FXY-049-FLK
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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